Z-1162-2009

Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN; Reorder...

Name: Z-1162-2009 Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN; Reorder...
Creator: Tri-State Hospital Supply Corporation
Published: 2009-01-14
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2009-01-14 / Terminated / root cause: packaging

FDA source

Tri-State Hospital Supply Corporation began a recall of Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN; Reorder CVI1025 on 2009-01-14. The reason FDA records is "Lack of assurance of sterility, as the package seals may be inadequate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1162-2009
Status: Terminated
Initiated: 2009-01-14
Posted: 2009-03-25
Terminated: 2009-12-31
Recalling firm: Centurion Medical Products, LP
Product: Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN; Reorder CVI1025.
Product code: LRS I.V. Start Kit
Reason for recall: Lack of assurance of sterility, as the package seals may be inadequate.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
Quantity in commerce: 75
Distribution: Nationwide.
Product codes and lots: Lot 2008111750.

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)